U.S. patent application number 11/234097 was filed with the patent office on 2007-03-29 for therapeutic soap product with uv protection.
Invention is credited to Jamie Collins Doss.
Application Number | 20070071698 11/234097 |
Document ID | / |
Family ID | 37894257 |
Filed Date | 2007-03-29 |
United States Patent
Application |
20070071698 |
Kind Code |
A1 |
Doss; Jamie Collins |
March 29, 2007 |
Therapeutic soap product with UV protection
Abstract
The present invention concerns a cleansing composition that
imparts sun protection for the skin through normal daily use during
bathing, washing, or cleaning of the body or face. The cleansing
composition of the present invention comprises a unique combination
of ingredients that provides therapeutic and restorative properties
for the skin.
Inventors: |
Doss; Jamie Collins; (Santa
Fe, NM) |
Correspondence
Address: |
John J. Yim, Esq.
4th Floor
1750 Tysons Blvd.
McLean
VA
22102
US
|
Family ID: |
37894257 |
Appl. No.: |
11/234097 |
Filed: |
September 26, 2005 |
Current U.S.
Class: |
424/59 ; 424/74;
424/744; 424/748; 424/769 |
Current CPC
Class: |
A61K 36/328 20130101;
A61K 36/886 20130101; A61K 2300/00 20130101; A61K 2300/00 20130101;
A61K 2300/00 20130101; C11D 9/18 20130101; A61K 36/886 20130101;
A61K 36/328 20130101; A61K 36/63 20130101; C11D 9/30 20130101; C11D
9/38 20130101; A61K 36/63 20130101 |
Class at
Publication: |
424/059 ;
424/748; 424/074; 424/744; 424/769 |
International
Class: |
A61K 8/97 20060101
A61K008/97; A61K 8/27 20060101 A61K008/27; A61K 8/29 20060101
A61K008/29; A61K 36/328 20060101 A61K036/328; A61K 36/886 20060101
A61K036/886 |
Claims
1. A cleansing composition in soap bar form for providing UV
protection through normal use of washing and rinsing and for
therapeutic and restorative properties, comprising: a natural soap
base for cleaning the skin; physical sunblocks, titanium dioxide
and zinc oxide, for providing protection against UV rays, wherein
said physical sunblocks are in ultrafine or microfine form;
chlorophyll for promoting wound healing, detoxifying, deodorizing,
and inhibiting bacterial growth; citric acid for providing a mild
exfoliant to help remove dead skin cells and help skin regenerate;
healing balm of Gilead prepared from one or more selected from the
group consisting of Old World balm of Gilead, Canary Island balm of
Gilead, and American or Canadian balm of Gilead, for improving and
preventing skin disorders; aloe vera prepared from whole leaf of
aloe vera for restoring damaged skin tissues and cells; vitamins
further comprising one or more selected from the group consisting
of A, C, D, E, K, B1, B2, Niacin, B6, B12, folic acid, and biotin;
olive oil for moisturizing and keeping skin hydrated; minerals
further comprising one or more selected form the group consisting
of Ca, Fe, P, Mg, Zn, Se, and Cu; and amino acids, wherein the
cleansing composition is in soap bar form.
2. The cleansing composition according to claim 1, wherein the
cleansing composition does not contain preservatives.
3. The cleansing composition according to claim 1, wherein the
cleansing composition consists of hypoallergenic ingredients.
4. The cleansing composition according to claim 1, wherein the
natural soap base is glycerin.
5. The cleansing composition according to claim 1, wherein the
natural soap base is a plant derived soap base.
6. The cleansing composition according to claim 1, wherein the zinc
oxide is nanospheric in form.
7. The cleansing composition according to claim 1, wherein the
citric acid is lemon juice.
8. The cleansing composition according to claim 1, wherein the balm
of Gilead is prepared from resinous juice.
9. The cleansing composition according to claim 1, wherein the balm
of Gilead is selected from the group consisting of Populus
Candicans, P. Nigera, and P. Balsamifera.
10. The cleansing composition according to claim 1, wherein the
balm of Gilead is prepared from Populus Candicans.
11. The cleansing composition according to claim 1, wherein the
aloe vera further comprises one or more selected from the group
consisting of vitamins, minerals, enzymes, sugars, lignins,
saponins, and amino acids.
12. The cleansing composition according to claim 1, wherein the
vitamin is a multi-vitamin.
13. The cleaning composition according to claim 1, wherein the
amino acids are naturally made amino acids.
14. The cleaning composition according to claim 1, further
comprising one or more selected from the group consisting of
fragrance, oil, fat, water, bactericide, anti-viral agent,
anti-fungal agent, colorants, anti-oxidants, and foaming
improvers.
15. A method of providing sunscreen to the skin by washing and
rinsing with a cleansing composition, wherein the cleansing
composition is in soap bar form, wherein the cleansing composition
provides therapeutic and restorative properties, wherein the soap
composition comprises: a natural soap base for cleaning the skin;
physical sunblocks, titanium dioxide and zinc oxide, for providing
protection against UV rays, wherein said physical sunblocks are in
ultrafine or microfine form; chlorophyll for promoting wound
healing, detoxifying, deodorizing, and inhibiting bacterial growth;
citric acid for providing a mild exfoliant to help remove dead skin
cells and help skin regenerate; healing balm of Gilead prepared
from one or more selected from the group consisting of Old World
balm of Gilead, Canary Island balm of Gilead, and American or
Canadian balm of Gilead, for improving and preventing skin
disorders; aloe vera prepared from whole leaf of aloe vera for
restoring damaged skin tissues and cells; vitamins further
comprising one or more selected from the group consisting of A, C,
D, E, K, B1, B2, Niacin, B6, B12, folic acid, and biotin; olive oil
for moisturizing and keeping skin hydrated; minerals further
comprising one or more selected form the group consisting of Ca,
Fe, P, Mg, Zn, Se, and Cu; and amino acids.
16. A method of making a soap bar composition for imparting UV
protection on the skin by washing and rinsing with the cleansing
composition, mixing the following ingredients in a soap base:
chlorophyll for promoting wound healing, detoxifying, deodorizing,
and inhibiting bacterial growth; citric acid for providing a mild
exfoliant to help remove dead skin cells and help skin regenerate;
healing balm of Gilead prepared from one or more selected from the
group consisting of Old World balm of Gilead, Canary Island balm of
Gilead, and American or Canadian balm of Gilead, for improving and
preventing skin disorders; aloe vera prepared from whole leaf of
aloe vera for restoring damaged skin tissues and cells; vitamins
further comprising one or more selected from the group consisting
of A, C, D, E, K, B1, B2, Niacin, B6, B12, folic acid, and biotin;
olive oil for moisturizing and keeping skin hydrated; minerals
further comprising one or more selected form the group consisting
of Ca, Fe, P, Mg, Zn, Se, and Cu; and amino acids adding titanium
dioxide to the soap mixture; adding zinc oxide to the titanium
dioxide added soap mixture.
17. The method according to claim 16, wherein the soap base is
glycerin.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This patent application is related to a concurrently filed
utility patent application entitled "Therapeutic Soap Product with
UV Protection," filed on Sep. 9, 2005, and assigned Ser. No.
______. The concurrently filed application is incorporated herein
by reference.
INTRODUCTION
[0002] The sun is vital and necessary for almost all forms of life.
But it is well documented that overexposure to the sun's
ultraviolet ("UV") rays harms the skin. The sun's UV rays damage
the skin and cause premature aging and sunburns. It is the primary
cause of skin cancer. New incidences of skin cancer are estimated
to exceed 1.3 million cases each year. Two new cases of skin cancer
are diagnosed every minute, and one person dies of skin cancer
every hour.
[0003] Despite these known dangers, however, most people do not
take the necessary precautions to protect themselves from
overexposure to the sun. Surveys have found that one in seven
adults do nothing to protect themselves from the sun. When asked
why, one in three adults answered that they simply forgot.
[0004] Solar UV radiation causes damage to cell membranes and the
DNA molecules inside the cells. It also helps break down collagen
fibers and elastin, which are proteins that are vitally important
for maintaining the skin's structural integrity. UV radiation
causes collagen to break down faster than with the normal aging
process. Repeated overexposure to the sun causes a thickening of
the skin that produces a tough, leathery skin and unsightly changes
in skin pigmentation. Overexposure to the sun and its UV rays
cosmetically harms the skin, causing freckles, wrinkles, premature
skin aging, solar lentago, solar elastosis, and pigment coloration
changes, among other skin blemishes.
[0005] As people increasingly engage in the modern outdoor
lifestyle, these health and cosmetic concerns become more urgent.
Furthermore, increasing depletion of the ozone layer and increasing
pollution continue to exacerbate the sun's harmful effect. UVA
rays, which comprise approximately 90-95% of the sun's ultraviolet
light, have a relatively long wavelength in the 320-400 nanometer
range. UVA rays are not absorbed by the ozone layer and are the
primary cause of initial stages of a tan. UVB rays, with medium
wavelength of about 290-320 nanometers, are partially absorbed by
the ozone layer and are the primary cause of a sunburn.
[0006] For health and cosmetic benefits, overexposure to the sun
should be avoided, and sunscreen products should be used when going
out into the sun. Various sunscreen products have been developed
and widely used for protection against UVA and UVB rays. The
skin-care market currently sells sunscreen products generally in
two different forms: as chemical absorbers or as physical
blockers.
[0007] Chemical sunscreens contain one or more UV absorbing
chemical components such as abovenzone, octocrylene, benzophenones,
salicylate, and cinnamates. Although they are effective in
shielding the body against the sun's effect, they also cause
adverse skin reactions. Some studies have also found that chemical
sunscreens generate harmful free radicals and may actually increase
the risk of cancer. Some commonly used chemical sunscreens also
have strong estrogenic actions that may lead to complications.
[0008] In contrast, physical blockers or inorganic sunscreens
physically scatter and reflect UVB and UVA rays. Physical
sunblocks, such as zinc oxide or titanium dioxide, are not absorbed
by the skin and are not known to cause health complications.
[0009] In addition to the time consuming nature of proper
application, sunscreen products can be difficult to apply over the
whole body. Even when applied properly, it must be applied
repeatedly and in ample amounts. Additionally, a sunscreen lotion
may be uncomfortable for some because of the oily/greasy feel it
may leave behind. Thus, there is a need for a product that allows
its users to apply sunblock on a daily basis in a convenient and
easy manner.
[0010] The skin is also the body's largest organ. The epidermis,
which is the outermost layer, functions primarily as a protective
barrier, while the dermis is the underlying layer. The skin
provides the vital function of protecting the body against physical
and chemical elements. The blood vessels in the skin also regulate
body temperature, and the skin functions as an important sensorial
tool. In addition to providing protection and regulating the body,
the skin also functions as a shock absorber and an insulator.
[0011] No matter the age or skin type, proper skin care also
involves proper cleaning, nourishing, moisturizing, and protecting.
A good cleanser or soap rids the skin of the dirt and pollutants
that accumulate over the course of a day without causing drying or
adverse reaction. As an important and active organ, the skin also
needs to be nourished with nutrients and moisturizers.
[0012] As an active organ, the skin is also susceptible to damages
and ailments. Sunburns caused by overexposure should be treated
promptly. Likewise, skin conditions such as eczema, acne, irregular
pigmentation and the like should also be treated. Thus, there is a
need for a skin product that simultaneously provides therapy and
maintenance for healthy skin. Thus, there is a need in the art for
an improved skin cleansing composition that safely washes and
therapeutically treats the skin, while applying sunblock through
the normal use of the soap.
[0013] The cleansing composition of the present invention applies
sunscreen protection to the skin through the normal routine of
bathing or washing with a bar of soap. As a result, it can be
applied to the whole body and face quite efficiently and better
suited for use on a daily basis. The composition is also suited for
frequent use because of the non-greasy, all natural, and
hypoallergenic formulation. The soap composition of the present
invention further comprises ingredients that strengthen and nourish
the skin.
[0014] For those with fair or sensitive skin, the cleansing
composition of the present invention provides additional
advantages. The present invention allows those with sensitive skin
to wear sunscreen protection without forgetting. Additionally, the
present invention does not have harsh or unnatural ingredients and
thus makes it appropriate for individuals with sensitive skin.
[0015] Another advantage of the present invention is that it is a
therapeutic product. A therapeutic product generally heals and
nourishes the skin, thereby promoting a healthier skin. Just as one
cares for the internal part of the body by eating the right foods
and taking vitamins, the soap composition of the present invention
also nourishes and cares for the skin by providing various
therapeutic ingredients. The unique formulation of the present
invention provides manifold advantages: it gently cleans the skin,
it protects the skin against the sun, and it nurtures and heals the
skin.
SUMMARY OF INVENTION
[0016] The present invention concerns a cleansing composition that
applies sunblock to the skin through normal daily use. The
cleansing composition is preferably in a soap bar form. In normal
use, users will generally wash with the soap bar and rinse off with
water in the ordinary course of washing. Despite rinsing off, the
composition of the present invention imparts and leaves behind a UV
protectant for the skin.
[0017] The cleansing composition of the present invention also
provides therapeutic benefits to the skin. The present invention
comprises a unique combination of ingredients that provides
therapeutic and restorative properties for the skin. Repeated use
of the composition of the present invention reduces skin ailments
and cosmetic blemishes such as acne, freckles, and age spots. The
composition is especially useful for those with sensitive and fair
skin. The all-natural based formulation leaves no noticeable oil or
residues that may cause adverse skin reactions. Because the present
invention is also gentle for daily use even by those with the most
sensitive skin, it can be used regularly without harm or side
effect. The soap composition of the present invention also
preferably does not use any non-natural ingredients and preferably
does not use allergic ingredients.
[0018] The present invention comprises a natural soap base.
Preferably, glycerin, a natural humectant, is used as the soap
base. Glycerin is hypo-allergenic and safe for use on sensitive
skin. Other hypo-allergenic soap bases may also be used as known in
the art. For example, the soap base may comprise approximately
15-20% pure glycerin, to which may be added approximately 7-13%
additional lipids. Preferably, vegetable or plant derived soap
bases are chosen. Olive oil or coconut oil bases may also be used,
but lye derived soap bases are preferably avoided.
[0019] As UV protectants, the soap bar composition of the present
invention comprises physical sunblocks, titanium dioxide and zinc
oxide. These physical sunblocks keep UVA and UVB rays from reaching
the skin, and they block the UV rays rather than absorbing them
like chemical sunscreens.
[0020] In preferred embodiments, ultrafine or microfine forms of
these physical sunblocks are used. Their small size makes them
clear and cosmetically suitable. More preferably, the zinc oxide is
in nanospheric form to allow for better blending with the other
ingredients of the present invention. Titanium dioxide and zinc
oxide also possess therapeutic properties that are beneficial to
the skin. Preferably, titanium dioxide and zinc oxide are blended
or paired together in making the inventive composition.
[0021] In addition to the soap base and the physical UV
protectants, the soap composition of the present invention further
comprises the following ingredients: chlorophyll, citric acid, the
healing balm of Gilead, aloe vera, vitamins, minerals, olive oil,
and amino acids.
[0022] In adding these ingredients, the liquid to powder ratio is
balanced to provide for optimal texture, consistency and hardness
of the resulting soap product. For example, the amount of liquid
added is adjusted so that the resulting product will have optimal
texture, consistency and hardness of a soap bar as known in the
art. If too much powder ingredients are used, for example, the soap
product may have inappropriate texture, consistency and hardness.
Many of the ingredients can be used in either liquid or powder (or
solid) forms, and the final consistency, texture and hardness of
the soap product should be considered in making the adjustments. As
known in the art, different combinations of liquid to powder
proportions may be used.
[0023] Chlorophyll, for example, may be added in either liquid or
powder form. Preferably, chlorophyll is added in liquid form. The
chlorophyll used in the present invention is preferably made
without additives or preservatives. In some embodiments,
chlorophyll may be added in both powder and liquid forms.
Chlorophyll promotes skin restoration and skin therapy and provides
treatment for bums, sunburns, abrasions and skin irritations. It
also gives the soap product of the present invention anti-bacterial
and detoxifying properties.
[0024] Alpha-hydroxy acids, preferably organic acids, and more
preferably citric acids are also added in the inventive compound.
These alpha-hydroxy acids are derived from foods, such as milk,
wine, fruits and citrus. Citric acids are used at low
concentrations, and they help gently exfoliate the skin. It helps
remove the outer layer of dead skin cells and thus helps the skin
in its natural regenerating process. The citric acid helps the skin
achieve and maintain a smoother, fresher, younger-looking skin and
increases the skin's thickness. Also functioning as a skin
moisturizer, the citric acid improves the overall tone of the skin
and reduces lines. Since too much alpha-hydroxy acids may render
the skin sensitive, low concentrations are added to the present
invention. Furthermore, the sunscreen in the inventive composition
further protects the skin from being damaged by the sun.
[0025] The present invention also comprises the healing balm of
Gilead. The balm is prepared from one or more of the following
plants. The Old World balm of Gilead, or Mecca Balsam, is a small
evergreen tree native to Asia and Africa. The American balm of
Gilead is a species of poplar, populus candicans of the willow
family. Also, balsam poplar varieties may also be use as well as
the Cedronella canariensis variety from the Canary Island and the
United States. The balm of Gilead is preferably used in liquid form
rather than in its bulbous form. The balm of Gilead gives the soap
composition therapeutic healing properties. The balm of Gilead
helps disinfect the skin, act as a stringent, treat eczyma and
other skin disorders, and relieve dry, scaly and itchy skin.
[0026] In addition, the present invention comprises aloe vera,
which may be used in powder, juice or gel form. The aloe vera is
preferably prepared from the whole leaf of the plant. Juice
preparations are preferred, and gel forms are the more preferred
embodiments. The aloe vera provides natural vitamins, minerals,
enzymes, minerals, sugars, and other beneficial natural
ingredients. The aloe vera opens up the pores of the skin, helps
repair damaged skin tissues, moisturizes and hydrates the skin,
rejuvenates the skin, and helps reduce and prevent skin blemishes
and wounds.
[0027] The soap composition of the present invention also comprises
all natural vitamins, minerals and amino acids. Preferably, an
all-in-one powder multivitamin is used. Furthermore, beneficial
mineral are provided preferably in low dosage. Finally, natural
amino acids are also included to further help nourish the skin.
[0028] The present invention further comprises olive oil.
Preferably, all-natural, 100% olive oil is used. Olive oil
functions as an emollient and is useful in treating skin ailments
such as psoriasis, excema and dermatitus treatment. It also helps
keep the skin hydrated and functions as a lotion. It relieves dry
skin and reduce scaling and inflammation.
[0029] Optional ingredients for the inventive composition include,
among others, lavender, rosemary and other herbs and fragrances,
natural oils, rose absolute and other fragrances, plant extracts,
water, emulsifiers, bactericides, humectins, colorants, chelating
agents, anti-oxidants and foaming improvers.
[0030] Furthermore, the present invention also comprises a method
of making the soap bar product of the present invention, wherein
the first step involves mixing all of the ingredients, except the
titanium dioxide and zinc oxide, with a glycerin soap base. The
second step involves: first adding the titanium dioxide; and second
adding the zinc oxide.
[0031] The present invention concerns a soap product formulated and
processed to provide one or more of the following advantageous
properties: sunscreen protection through normal use (washing with
and rinsing) with the soap product of the present invention; a
natural skin absorber that penetrates the skin to a deep level to
enhance the skin; nutrients to feed and nourish the skin to create
and maintain healthier skin with improved complexion and more
abundant collagen; reduction of acne, aging spots, and freckles
with consistent use; and a gentle soap product with no harsh
additive or unnatural ingredients.
[0032] Furthermore, the present invention also concerns a soap
composition with optimal proportions of various ingredients for
optimizing-SPF rating of the soap. Although it is generally
expected that higher amounts of zinc oxide and titanium oxide would
lead to higher SPF ratings, it has been found that increasing the
amount of zinc oxide and titanium dioxide does not necessarily
maximize the sunscreen SPF factor for the soap product.
[0033] Preferably, the amount of zinc oxide is added in greater
proportion than the amount of titanium dioxide. For optimal SPF
efficacy, the two physical sunblock ingredients, zinc oxide and
titanium dioxide, are added in following proportions: [0034]
approximately 2 portions by weight of zinc oxide; to [0035]
approximately 1 portion by weight of titanium dioxide. In one
preferred embodiment, in preparing a 1.36 kg preparation of the
present invention, approximately 7 g of zinc oxide is added, and
approximately 3 g to 4 g of titanium dioxide is added.
[0036] Alternatively, approximately 0.4 % to 0.6 % by weight of the
soap composition is preferably zinc oxide, and approximately 0.15 %
to 0.3 % by weight of the soap composition is preferably titanium
dioxide. Most preferably, approximately 0.5 % by weight of the soap
is zinc oxide, and approximately 0.2 % by weight of the soap is
titanium dioxide.
[0037] Furthermore, in one embodiment, in making a 1.36 kg
preparation of the present invention, the following additional
ingredients are added in the following proportions to optimize SPF
ratings: [0038] approximately 5 ml of balm of Gilead [0039]
approximately 10 ml of chlorophyll [0040] approximately 8 g of
multivitamin mixture [0041] approximately 5 ml of olive oil [0042]
approximately 5 ml of aloe vera [0043] approximately 15 ml of lemon
juice. Deviation from these proportions will continue to provide
sunscreen protection. However, the soap composition of the present
invention with these proportions are preferred.
[0044] Some of the preferred embodiments of the present invention
are discussed below. As the present invention may be embodied in
several forms without departing from the spirit or essential
characteristics thereof, it should also be understood that the
description contained herein is not limited by the details of the
foregoing description, unless otherwise stated. The present
invention should be construed within its spirit and scope, and
therefore all changes and modifications that fall within the meets
and bounds of the claims, or equivalences of such meets and bounds
are therefore intended to be embraced by the invention.
[0045] The embodiment described below refers to approximate ranges
of amounts of individual ingredients used to make approximately
1.36 kg (3 lb.) preparation of the soap of the present invention.
Larger and small preparations may be made as known in the art.
DETAILED DESCRIPTION
[0046] The present invention concerns a soap base product that
comprises physical UV protectants titanium dioxide and zinc oxide,
wherein the UV protectants are applied to the skin by using the
soap during normal wash. The soap composition of the present
invention further comprises a soap base, chlorophyll, alpa-hydroxy
acids (preferably citric acids), the healing balm of Gilead, aloe
vera, multivitamins, minerals, olive oil and amino acids.
[0047] The present invention also optionally comprises ingredients,
among others, lavender, rosemary and other herbs and fragrances,
and other natural oils, rose absolute and other fragrances, plant
extracts, water, emulsifiers, bactericides, humectins, colorants,
chelating agents, anti-oxidants and foaming improvers.
[0048] Titanium Dioxide and Zinc Oxide
[0049] The present invention comprises two sunblock ingredients,
titanium dioxide (TiO.sub.2) and zinc oxide (ZO). Titanium dioxide
and zinc oxide are well known physical UV blocking pigments.
Titanium dioxide and zinc oxide are both very gentle on the skin.
Zinc oxide, for example, is often used to treat diaper rash in
infants and is a known therapeutic agent for the skin.
[0050] Physical sunblocks such as titanium dioxide and zinc oxide
differ from chemical sunscreens in that they are not absorbed by
the skin, but rather lie on top of the skin and prevent the UV rays
from reaching the skin.
[0051] Microfine or ultrafine forms of titanium dioxide and zinc
oxide are preferably used in the present invention. For the
Titanium dioxide, a micronized version (microfine or ultrafine) is
preferably used. Whereas pigmentary titanium dioxide is about 200
nm in size, ultrafine titanium dioxide is approximately 20 nm in
size. These small particles are transparent and do not leave a
visible residue. A micronized version of the TiO.sub.2 is clear and
provide equal amount of sunblocking capability.
[0052] TiO.sub.2 is commercially available from various
manufacturers. One suitable vendor is Kemira. TiO.sub.2 from
Kemira, UV-TITAN, is ultrafine transparent titanium dioxide, which
increases protection against ultraviolet radiation and gives
special effects in combination with metallic pigments. Kemira's
titanium dioxide contains needle and spherical shaped crystals.
[0053] For ZnO, a micronized (ultrafine, microfine or nanospheric)
version is also preferably used. More preferably, ZnO is in
nanospheric form. The smaller particle size of the nanospheric form
allows for better dispersion and interaction of ZnO with the other
ingredients. Microfine zinc oxide provides stable and effective
protection against ultraviolet radiation. Zinc oxide provides
protection against UVB and UVA uniformly protecting from 290 to 380
nm. ZnO does not react with organic sunscreens when irradiated.
Additionally, Zinc Oxide also gives the soap composition of the
present invention anti-inflammatory qualities and helps calm
irritated skin. Furthermore, ZnO also renders the inventive
composition a skin protectant and wound healing adjuvant. Because
ZnO is not absorbed into the body, it can safely be used with
causing side effects.
[0054] ZnO from various manufacturers may be used. NanoActive.TM.
Zinc Oxide form NanoScale Material, ultrafine and cosmetic grade
(formula weight 81.37, catalog number 10-100), is one example. In
other embodiments, Z-COTE.RTM., which is a microfine ZnO, may also
be used. Zinc oxide and the titanium dioxide are preferably paired,
blended, or mixed together.
[0055] For a 1.36 kg preparation of the present invention, zinc
oxide is added preferably at approximately between 2 g and 20 g,
more preferably between approximately 3 and 10 g, and even more
preferably between 6 and 8 g. Most preferably, approximately 7 g of
zinc oxide is added.
[0056] For a 1.36 kg preparation of the present invention, between
approximately 1 and 14 g of titanium dioxide is preferably added.
More preferably, between approximately 2 and 5 g of titanium
dioxide is added. Most preferably, approximately 2.5 to 3.5 g of
titanium dioxide is added.
Chlorophyll
[0057] Chlorophyll is another active ingredient in the present
invention, which provides therapeutic characteristics to the soap
bar. The chlorophyll molecule is chemically similar to hemoglobin,
the oxygen carrying element of human blood, except that
chlorophyll's central atom is magnesium instead of iron.
Preferably, the chlorophyll used in the present invention does not
have any additives or preservatives. Chlorophyll can be added in
liquid or powder form, more preferably in liquid form.
[0058] As an active ingredient in the present invention,
chlorophyll promotes skin restoration and provides skin therapy.
For example, chlorophyll helps the soap product of the present
invention treat ulcerative lesions and burns. Chlorophyll also
helps sooth burned and sunburned skin and provides pain relief,
acting as a skin refresher.
[0059] Chlorophyll allows the present inventive compound to
accelerate wound healing and stimulate damaged tissue repair.
Chlorophyll also helps inhibit the growth of bacteria and therefore
helps the soap composition function as a bacterio-static agent.
Chlorophyll helps the soap composition provide an environment that
interferes with bacterial growth. It also helps stimulate the
growth of healthy granuloma tissue and fibroblasts. Furthermore,
chlorophyll also helps the soap composition detoxify and deodorize.
Thus, chlorophyll promotes wound healing, detoxifies and
deodorizes, and inhibits bacterial growth.
[0060] In making a 1.36 kg preparation of the present invention,
chlorophyll is preferably added at approximately between 5 and 20
ml, and more preferably at approximately between 7 ml and 15 ml.
Most preferably, chlorophyll is added at approximately 10 ml.
[0061] Chlorophyll can be obtained from various manufacturers,
including Nature's Sunshine. Chlorophyll by Nature's Sunshine
contains photosynthetic chlorophyll and is made from alfafa. Any
suitable source may be used for making chlorophyll as known in the
art.
Citric Acid
[0062] The present invention further comprises an alpha-hydroxy
acid. Preferably citric acid and more preferably lemon juice may be
used. Alpha-hydroxy acids dissolve the cement that holds dead skin
cells together and influences the structure of new stratum corneum
being made. When citric acids is added at low concentration, it
allows the soap composition to act as a mild exfoliant.
[0063] It also helps the skin absorb the other ingredients of the
present invention by removing dead outer layers of the skin. Citric
acid also helps the skin in its natural regenerating process by
fading age spots and making the skin more flexible and smoother.
Also functioning as skin moisturizers, the citric acid improves the
overall tone of the skin and reduces lines and wrinkles.
[0064] In making a 1.36 kg preparation of the present invention,
lemon juice is preferably added at amounts of approximately between
5 and 25 ml, and more preferably between approximately 10 and 20
ml. Most preferably, citric acid is added at approximately 15
ml.
Healing Balm of Gilead
[0065] The soap bar composition of the present invention further
comprises the healing balm of Gilead. The balm of Gilead salve is
made from one or more of the following balms of Gilead: Old World
balm of Gilead, Canary Island balm of Gilead or the American balm
of Gilead. Preferably, the balm is prepared from resinous juice of
these plants.
[0066] Preferably, the historic Old World balm of Gilead, or Mecca
balsam, is a small evergreen tree (Commiphora gileadensis or C.
opobalsamum) of the family Burseraceae (incense-tree family), which
is native to Africa and Asia and a common source of the commercial
balm of Gilead. The American balm of Gilead is preferably a species
of poplar tree (Populus candicans) of the family Salicaceae (willow
family) which has large balsamic and fragrant buds. The poplar is
closely related to, and sometimes considered a variety of, the
balsam poplar (P. tacamahaca, P. Nigra and P. balsamifera), which
has also been called balm of Gilead and tacamahac. The balm of
Gilead may preferably also include the balsam fir and for
herbaceous aromatic, shrubby plant (Dracocephalum canariense or
Cedronella canariensis) of the family Labiatae (mint family) native
to the Canary Islands and cultivated in parts of the United States.
Also Abies Balsamea, Balm of Gilead Fir, or American Silver Fir,
are names applied to Canadian species. Descriptions of the balm of
Gilead from bontanical.com and encyclopedia.com are incorporated
herein by reference.
[0067] Some additional synonyms of balm of Gilead include, among
others: Balsamum Meccae var. Judiacum; Balsamum Gileadense; Baume
de la Mecque; Balsamodendrum Opobalsamum; Balessan; Bechan; Balsam
Tree; Amyris Gileadensis; Amyris Opobalsamum; Balsumodendron
Gileadensis; Protium Gileadense; and Dossemo.
[0068] The balm of Gilead provides therapeutic properties to the
soap bar composition of the present invention. It helps disinfect
the skin and act as an astringent. It also helps improve and
prevent eczyma and other dry skin disorders. The balm of Gilead
also provides treatments for skin infections, pimples, swellings,
blemishes and other skin diseases. It also moisturizes and soothes
the skin. Additionally, the balms referred to above pair well with
the soap base, glycerin, providing the right texture to maximize
sunscreen protection and penetration of the skin.
[0069] The balm of Gilead may be purchased from various commercial
sources. One example is the balm of Gilead manufactured by Desert
Herbals, Populus Candicans. Preferably, the balm of Gilead is added
in liquid form. Powdered forms may be used. More preferably, the
resinous liquid collected from the buds of the plants is used.
Preferably, the balm of liquid used in the present invention is not
processed from a different oil or wax.
[0070] Specifically, in a preferred embodiment, the balm of Gilead
is derived from Populus Candicans. In another preferred embodiment,
the balm of Gilead used is P. Nigera. In another preferred
embodiment, the source is P. Balsamifera.
[0071] For a 1.36 kg preparation of the present invention,
approximately 2 to 40 ml of balm of Gilead may be added. More
preferably, between approximately 5 to 20 ml may be added. Most
preferably approximately 5 ml of balm of gilead is added to a 1.36
kg preparation of the present invention.
Aloe Vera
[0072] The present invention further comprises aloe vera, which may
be in liquid, gel or powder form. Liquid or gel forms are
preferred. The aloe vera ingredient is preferably prepared using
the whole leaf. Aloe vera, available commercially from various
sources, may be used, and preferably the aloe vera should be
prepared without additives or preservatives.
[0073] For a 1.36 kg preparation of the present invention,
approximately 5 to 45 ml of aloe vera may preferably be added, and
more preferably, 10 to 30 ml of aloe vera may be added. Most
preferably, approximately 15 ml of aloe vera is added for a 1.36 kg
preparation of the present invention.
[0074] Aloe vera itself comprises various components that are
beneficial and therapeutic for the skin. (See positivehealth.com).
Aloe vera contains vitamins, especially vitamin D and antioxidants
vitamin A (beta-carotene), C and E and even traces of vitamin B 12.
Aloe vera also contains small amounts of minerals such as calcium,
sodium, potassium, manganese, magnesium, copper, zinc, chromium and
selenium. As discussed in more detail below, these essential
vitamins and minerals are delivered to the skin through the soap
bar of the present invention. Additionally, beneficial enzymes such
as bradykinase in the aloe vera help reduce inflammation of the
skin when applied topically through the soap bar of the present
invention.
[0075] Moreover, sugars in the aloe vera function as moisturizers
and help detoxify the skin. Anthraquinones, which are phenolic
compounds found in aloe vera, also enhance the soap bar's
anti-bacterial and anti-viral properties. Additionally, lignins
better allow the aloe vera to be absorbed into the skin. Saponins,
which are soapy substances, have cleansing and antiseptic
properties and function as anti-microbial, anti-bacterial,
anti-viral, anti-fungal, and anti-yeast agents. Furthermore, small
amounts of fatty acids present in aloe vera further give the soap
composition anti-inflammatory characteristics. Salicyclic acid,
which is also present in aloe vera, acts as anti-inflammatory and
anti-bacterial agents. Finally, aloe vera contains 20 out of 22
amino acids, and 7 out of 8 amino acids, which cannot be
synthesized by the body.
[0076] Aloe vera allows the present composition to work on damaged
skin tissues and cells. It helps the soap composition heal bums,
reduce eczema, and relieve skin irritations. Repeated use helps
heal skin ulcers, prevents scarring, and rejuvenates the skin.
Furthermore, it helps the soap moisture and hydrate the skin and
leads to a softer and smoother skin. The aloe vera is absorbed into
the skin to stimulate fibroblast replication and increases
production of collagen and estain fibers. Importantly, aloe vera is
hypo-allergenic and is generally safe for topical application.
Multivitamin, Minerals, and Amino Acids
[0077] Additional ingredients of the soap bar composition comprise
vitamins, minerals, and amino acids. Preferably, these ingredients
are added in powder form, but may also be added in liquid form. For
a 1.36 kg preparation of the soap composition, approximately 4 to
16 g of a mixture of vitamins, minerals, and amino acids are added.
More preferably approximately 8 g of a mixture of vitamins, mineral
and amino acids are added to a 1.36 kg preparation of the present
invention. Preferably, an all purpose multi-ingredient formulation
may be used.
[0078] Although the vitamin should preferably include A, C, D, E,
K, B1, B2, Niacin, B6, B12, folic acid, biotin, and others, one or
more of these vitamins may also be missing. The vitamins in the
soap composition provide added skin nutrition, replenish the skin
with lost vitamins, reduce environmental effects on the skin, and
help reverse signs of skin aging.
[0079] The soap composition of the present invention also comprises
one or more minerals, such as Ca, Fe, P, Mg, Zn, Se, Cu, among
others. Furthermore, natural amino acids are also added to the soap
composition. Although naturally made amino acids are preferred,
synthetic amino acids may also be used.
Soap Base
[0080] Glycerin is the preferred soap base in making the soap
composition of the present invention. Glycerin acts as a natural
humectant. Glycerin is hypo-allergenic and safe for use on
sensitive skin. Other hypo-allergenic soap bases may also be used
as known in the art. The soap base may comprise, for example,
approximately 15-20 % pure glycerin, to which may be added
approximately 7-13% additional lipids.
[0081] Preferably, vegetable or plant derived soap bases are
chosen. Olive oil or coconut oil bases may also be used. Hemp oil
and animal milk may also serve as the soap base. Lye derived soap
bases, however, are preferably not used.
Optional Ingredients
[0082] Optionally, the soap composition of the present invention
may also comprise one or more of the ingredients such as herbs or
fragrance, oils or fats, plant extracts, water, emulsifiers,
bactericides or anti-viral or anti-fungal agents, humectants,
colorants, anti-oxidants, foaming improvers, and more. As known in
the art, care should be taken to not add allergic ingredients.
Additional ingredients to facilitate the soap function may also be
incorporated as known in the art.
Method of Making
[0083] In making the soap composition of the present invention, the
first step comprises mixing all of the ingredients (minus TiO2
& Zinc) in a professional quality glycerin soap base. Various
commercially available soap making kits may be used. In the second
step, first, TiO2 is added to the soap mixture, and then second,
zinc oxide is added.
Preferred Proportions of Ingredients for Optimizing SPF Rating
[0084] Furthermore, the present invention also concerns a soap
composition with optimal proportions of various ingredients for
optimizing SPF rating of the soap. Preferably, the amount of zinc
oxide is added in greater proportion than the amount of titanium
dioxide.
[0085] For optimal SPF efficacy, the two physical sunblock
ingredients, zinc oxide and titanium dioxide, were used with the
following proportions: [0086] approximately 2 portions by weight of
zinc oxide; to [0087] approximately 1 portion by weight of titanium
dioxide In a 1.36 kg preparation, preferably, approximately 6-8 g
of ZnO and approximately 4-5 g of titanium dioxide is added.
[0088] Furthermore, in making a 1.36 kg preparation of the present
invention, the following additional ingredients are added in the
following proportions to optimize SPF ratings: [0089] approximately
5 ml of balm of Gilead [0090] approximately 10 ml of chlorophyll
[0091] approximately 8 g of multivitamin mixture [0092]
approximately 5 ml of olive oil [0093] approximately 5 ml of aloe
vera [0094] approximately 15 ml of lemon juice.
[0095] Testing results also showed that an overall increase in the
amount of sunblocks, titanium dioxide and zinc oxide, does not
necessarily increase the SPF rating and may actually decrease the
SPF rating in some examples.
Experimental Results
[0096] Experiments results are shown below for two different
batches of soap compositions of the present invention.
[0097] In Batch No. 1, the various ingredients maintained the
optimal SPF proportions discussed above. Thus, in Batch No. 1, zinc
oxide and titanium dioxide maintained a 2 to 1 proportionality,
respectively. For example, in making a 1.36 kg sample of the
present invention, approximately 7 g of zinc oxide was added and
approximately 3.5 g of titanium dioxide was added. Furthermore, the
balm of Gilead, chlorophyll, multivitamins, olive oil, aloe vera,
and lemon juice were added in proportions discussed above.
[0098] In Batch No. 2, however, with all other ingredients
remaining the same, more titanium dioxide was added than zinc
oxide. For a 1.36 kg preparation, approximately 10 g of zinc oxide
was added and approximately 20 g of zinc oxide was added.
[0099] As shown below, experimental results showed that Batch No. 1
showed a higher SPF protection. The results show that a 2:1 ratio
between zinc oxide and titanium dioxide provides optimal SPF
rating. The results show that it is desirable to have more zinc
oxide than titanium dioxide. Furthermore, even though Batch No. 2
had more sunblock ingredients, Batch No. 1 unexpectedly showed
better SPF rating.
Experimental Procedure and Results
[0100] SPF determination of the sunscreen soap was conducted by AMA
Laboratories utilizing a modification of the Final Monograph
procedure; "Sunscreen Drug Products for Over-The -Counter Human
Use," Final Rule, 21 CFR Part 352, Subpart D (Federal Register/Vol.
64, No. 98/Friday May 21, 1999).
[0101] These Batches were each subjected to two different tests.
The first test, "Not In Use" test, generally dissolved the soap
compositions in a 50% solution and applied it to human skin
subjects at a dose of 4 mg/cm.sup.2. After allowing the solution to
dry for 15 minutes, UV exposure testings were conducted. A second
test, "In Use" test, generally directed human subjects to lather
and rinse their skins with the soap compositions in a manner
normally associated with typical washing with a bar soap product.
Their skins were then exposed to UV rays from the solar
simulator.
[0102] Also, the samples submitted to AMA Labs for both Feb7 tests
were the same (called Sunsoap Batch 1 in the reports) and the
samples tested for the May 24/25 tests were the same (called
Sunscreen Soap 2 in the reports).
Test 1: Batch No. 1, "Not In Use" Test
[0103] Objective: The subject were convened to evaluate the
effectiveness of a test material as a sunscreen product by
determining the static Sun Protection Factor (SPF) on human skin
using a modification of the procedure as defined by the Final
Monograph; "Sunscreen Drug Products Fr Over-The-Counter Human Use",
Final Rule, 21 CFR Part 352, Subpart D (Federal Register/Vol. 64,
No. 98/Friday May 21, 1999, Proposed Amendment; Docket number
78N-0035/CP12, Jun. 21, 1999).
[0104] Batch No. 1: Batch No. 1, labeled Sunsoap Batch 1, was
received and assigned AMA Lab No.: K-7285. Upon arrival at AMA
Laboratories, Inc., the test material was assigned a unique
laboratory code number and entered into a daily log identifying the
lot number, sample description, sponsor, date received and testes
requested.
[0105] Five subjects were tested. The subjects' ages ranged between
23 and 59. They were female Caucasians. Standards of inclusion in
the study were, among others: individuals eighteen years of age or
older; individuals free of any dermatological or systemic disorder
which would interfere with the results; individuals free of any
acute or chronic disease that might interfere with or increase the
risk of study participation; individuals with Fitzpatricks skin
type 1, II, and II only; individual with no uneven skin tones,
pigmentation, scars, other irregularities or hair in test site
areas that would interfere with SPF determination; individual who
will complete a preliminary medical history form mandated by AMA
Laboratories, Inc. and are in general good health; individuals able
to cooperate with the Investigator and research staff, be willing
to have test materials applied according to the protocol, and
complete the full course of the study; individuals willing to
refrain from using any sunscreen products, sunbathing or tanning
bed use 24 hours prior to study initiation and the entire duration
of the study; and individuals with excessive hair on their back who
are willing to clip or shave their hair.
[0106] Standards of exclusion from the study were: individuals who
are under a doctor's care; individuals who are currently taking any
medication (topical or systemic) that may mask or interfere with
the test results; subjects with a history of any form of skin
cancer, melanoma, lupus, psoriasis, connective tissue disease,
diabetes or any disease that would increase the risk associated
with study participation; individuals diagnosed with chronic skin
allergies; individuals with a history of adverse effects upon sun
exposure; female volunteers who indicate that they are pregnant or
lactating; individuals with blemishes, nevi, sunburn, suntan,
scars, moles, active dermal lesions or uneven pigmentation in the
test sites; and individuals with known hypersensitivity to any
sunscreen products.
[0107] Healthy volunteers over the age of 18 years were recruited
for this study. The subjects consisted of fair-skin individuals
with skin types I, II, or III defined as follows (Federal Register
Vol. 64, No. 98, 27690, 1999) (Based on the first 30 to 45 minutes
sun exposure after a inter season of no sun exposure): Type
I--Always burns easily and never tans; Type II--Always burns easily
and tans minimally; Type III--Bums moderately and tans
gradually.
[0108] Institutional Review Board: A trained technician performed a
physical examination of the subjects' back to determine if study
eligibility criteria were satisfied. The Institutional Review Board
followed reference, CTR Title 21 Part 56, Subparts A, B, C, and D.
The IRB of AMA Laboratories, Inc. consisting of five or more
individuals, chosen from within the company for technical expertise
and from local community for lay interaction.
[0109] Artificial Light Source: The light source employed was a 150
watt Xenon Arc Solar Simulator (Solar Light Co., Philadelphia, Pa.
Model 14S or Model 16S) having a continuous emission spectrum in
the UVB range from 290 to 320 nm. Xenon arc is selected on the
basis of its black body radiation temperature of 6000.degree. K
which produces continuous UV spectra (all wavelengths)
substantially equivalent to that of a natural sunlight (Berger,
D.S.: Specification and Design of Solar Ultraviolet Simulators, J.
Invest, Dermatol. 53: 192-199, 1969).
[0110] The device was equipped with a dichroic mirror (which
reflects all radiation below 400 nm) and works in conjunction with
a 1mm thick Schott Wg-320 filter (which absorbs all radiation below
290 nm) to produce simulation of the solar UVA-UVB spectrum. A 1 mm
thick UG 11 filter (black lens) was added to remove reflected
(infra-red, grater than 700 nm) heat and remained visible
radiation. UVB radiation was monitored continuously during exposure
using a Model DCS- 1 Sunburn UV Meter/Dose Controller System (Solar
Light Co.) formerly known as the Robertson-Berger Sunburn Meter
(R-B meter). Measurements were taken at a position within 8 mm from
the surface of the skin. The field of irradiation was 1 cm in
diameter. The solar simulator was allowed a warm up time of at
least 15 minutes before use and power supply output was
recorded.
Procedure: (Static SPF Determination Including 8% Homosalate
Standard)
[0111] The infrascapular area of the back to the right and left
side of the midline was used. Within this area, 50 cm.sub.2
rectangular test sites were delineated with a gentian violet
surgical skin marker. Sites were observed to ensure uniform
pigmentation, skin tone and texture, and absence of warts, moles,
nevi, scars, blemishes and active dermal lesions. Any areas that
might be expected to produce erratic results were not used for UV
exposures.
[0112] The procedure for this study is outlined in the Federal
Register/Vol. 64, No. 98/Friday May 21, 1999. One test site area
served to determine each subject's Minimal Erythema Dose (MED). A
minimum of five UV exposures was administered within this site. The
individuals subject MED is the shortest time of exposure that
produces minimally perceptible erythema at 22 to 24 hours post
irradiation.
[0113] The test material, 8% homosalate standard were shaken and/or
swirled with a glass rod before use and were evenly applied using
plastic volumetric syringes to rectangular areas measuring 5
cm.times.10 cm (50 cm.sup.2) for a final concentration of 2.0 mg/cm
2. Evenness of application was verified by observation with a Woods
Lamp.
[0114] Fifteen minutes after application, a protected site received
a series of seven UV exposures based upon previously determined
MED. All immediate responses were recorded after UV radiation
exposure from the solar simulator.
[0115] The UV exposures for test material, 8% homosalate standard
were calculated from previously determined MED and the intended SPF
as follows. SPF 4: MED times 0.64x, 0.80x, 0.90x. 1.00x, 1.10x,
1.25x, and 1.56x. SPF 15: MED times 0.69x, 0.83x, 0.91x, 1.00x,
1.09x, 1.20x and 1.44x, where x equals the expected SPF of the
product.
[0116] Deviation From Protocol: Prior to application of the test
sample (AMA Lab No.: K-7285), it was allowed to dissolve in water,
such that it was diluted to a concentration of 50%. The prepared
solution was then delivered to the site at a dosage of 4.0
mg/cm.sup.2.
[0117] Fifteen minutes following the application procedure, the
protected site received a series of seven UV exposures based upon
previously determined MED.
[0118] Evaluation of Responses: Twenty-two to twenty-four hours
post exposure, the subjects are instructed to return to the testing
facility for evaluation of delayed erythemic responses. The
technician who evaluates the MED did not know the identity of the
test product application sites and UV exposures. Also he/she was
not the same person to have applied the sunscreen product to the
test site or administered the doses of UV radiation. SPF=Protected
MED/Final unprotected MED. Visual Grading Scale: [0119] 0=No
Erythema [0120] ?=Questionable Erythema [0121] 1=Minimal Erythema
[0122] 2=Slight Erythema [0123] 3=Well-Defined Erythema [0124]
4=Erythema and Edema [0125] 5=Erythema and Edema in vesicles
[0126] All technical employees of AMA Laboratories, Inc. were
required to take and pass a visual discrimination examination
conducted by a Board Certified Ophthalmologist using the
Farnsworth-Munsell 100 Hue Test as published; which determines a
person's ability to discern color against a black background. This
test was additionally modified to include a flesh tone background
more nearly approaching actual use conditions, wherein erythematous
skin is graded according to intensity.
[0127] Determination of the Test Products SPF Value and PCD/
Calculation of SPF and PCD: The mean SPF value (x) was calculated
using a minimum of 20 evaluable subjects per formulation. The
standard deviation was determined (s). The upper 5% point was
obtained from the t distribution table with n-1 degrees of freedom
(t). First, A was calculated as follows: A=(t)(s)/ (n) Therefore,
the label SPF for panels using a minimum of 20 evaluable subjects
was the largest whole number less the mean SPF minus A. Label
SPF=Mean SPF-A.
[0128] The Product Category Designation (PCD), for labeling
purposes, was assigned based on the mean SPF and PCD ranking
according to the reference. Classifications may be High, Moderate,
or Minimal. Because only five test panelists were included in this
study, no PCD was assigned.
[0129] Rejection Criteria: Panelist's results were rejected and the
panelist replaced if: 1) An exposure series fails to elicit and MED
response on the untreated skin, and the test is considered a
technical failure even if the MED response is observed in the
protected site; 2) The responses on the protected are randomly
absent, indicating uneven product spreading, non-constant light
irradiance or unstable product; and 3) All exposures in a series of
elicit responses--thus prohibiting any MED calculation.
[0130] Observations: No adverse effects or unexpected reactions of
any kind were observed on any of the subjects.
[0131] Results: The SPF of the above test material when tested on
five subjects as described herein under static, in-use, conditions
yielded the mean SPF of 13.95. The mean SPF of the 8% homosalate
standard on the same panel was 4.24. TABLE-US-00001 TABLE 1 (Batch
No. 1 (Not In Use Test): Sunsoap Batch 1) MED MED STD Subject MED/
I Skin I II (8% SPF ID # Sex Hr (Amps) Type J/M.sup.2 J/M.sup.2
HMS) Value 56 2392 F 125.8 7.0 II 46.20 46.20 4.00 13.65 36 0202 F
125.8 7.0 II 46.20 46.20 4.40 15.00 50 1415 F 125.8 7.0 II 46.20
46.20 4.40 15.00 40 1976 F 128.6 7.0 II 60.89 60.89 4.00 12.45 68
2925 F 125.9 7.0 II 46.20 46.20 4.40 13.65 Mean (x) 4.24 13.95
Standard 0.22 1.08 Dev (s) Std. Error 0.10 0.48 S.E. % of 2.36 3.44
Mean N 5 5 MED: Minimal Erythemal Dose I: Intensity of Light
Source
Test 2: Batch No. 1, "In Use" Test
[0132] In Test No. 2, Batch No. 1 (referred to as Sunsoap Batch 1
and assigned AMA Lab No.: K-7285) was conducted to an "In Use"
Test. The subjects tested were again five people, ranging in age
from 41 to 53, with 1 Caucasian male and 4 Caucasian females. No
adverse effects or unexpected reactions of any kind were observed
on any of the subjects.
[0133] The subjects underwent "In Use" tests, which directed the
subjects to lather and rinse their forearms with the soap
compositions in a manner normally associated with typical washing
with a bar soap product. Their formearms were then exposed to UV
rays from the solar simulator. Otherwise, same protocols were
followed as in the previous test.
[0134] Results: The SPF of the above test material when tested on
five subjects as described herein under static, in-use, conditions
yielded the mean SPF of 4.68. The mean SPF of the 8%
homosalate'standard on the same panel was 4.08. TABLE-US-00002
TABLE 2 (Batch No. 1 (In Use Test): Sunsoap Batch 1) MED MED STD
Subject MED/ I Skin I II (8% SPF ID # Sex Hr (Amps) Type J/M.sup.2
J/M.sup.2 HMS) Value 64 7285 F 125.5 7.0 II 60.89 60.89 4.40 4.00
54 3471 F 127.0 7.1 II 60.89 60.89 4.00 5.00 46 0816 F 128.3 7.0 II
46.20 46.20 4.00 5.00 40 5027 F 126.3 7.0 II 46.20 46.20 4.00 5.00
48 5699 M 126.8 6.9 II 46.20 46.20 4.00 4.00 Mean (x) 4.08 4.687
Standard 0.18 0.46 Dev (s) Std. Error 0.08 0.21 S.E. % of 1.96 4.49
Mean N 5 5 MED: Minimal Erythemal Dose I: Intensity of Light
Source
Test 3: Batch No. 2, "Not In Use" Test
[0135] In Test No. 3, Batch No. 2 (referred to as Sunscreen Soap 2
and assigned AMA Lab No.: K-7598) was subjected to a "Not In Use"
Test. The subjects tested were again five people, ranging in age
from 20 to 53, who were all Caucasian females. No adverse effects
or unexpected reactions of any kind were observed on any of the
subjects.
[0136] A "Not In-Use" evaluation procedure was followed as in Test
1. Prior to application of the test sample, it was allowed to
dissolve in water, such that it was diluted to a concentration of
50%. The prepared solution was then delivered to the site at a
dosage of 4.0 mg/cm.sup.2. Otherwise, same protocols were followed
as in the previous tests.
[0137] Results: The SPF of the above test material when tested on
five subjects as described herein under static, "In-Use" conditions
yielded the mean SPF of 11.85. The mean SPF of the 8% homosalate
standard on the same panel was 2.24. TABLE-US-00003 TABLE 3 (Batch
No. 2 (Not In Use Test): Sunscreen Soap 2) MED MED STD Subject MED/
I Skin I II (8% SPF ID # Sex Hr (Amps) Type J/M.sup.2 J/M.sup.2
HMS) Value 64 7285 F 125.4 7.8 II 60.89 60.89 4.40 10.35 46 9012 F
128.1 7.8 II 46.20 46.20 4.00 13.65 40 8279 F 126.2 7.8 II 46.89
46.89 4.40 12.45 50 1415 F 127.6 7.7 II 46.20 60.89 4.00 12.45 58
3434 F 126.5 7.2 II 30.33 30.33 4.40 10.35 Mean (x) 4.24 11.85
Standard 0.22 1.45 Dev (s) Std. Error 0.10 0.65 S.E. % of 2.36 5.49
Mean N 5 5 MED: Minimal Erythemal Dose I: Intensity of Light
Source
Test 4: Batch No. 2, "In Use" Test
[0138] In Test No. 4, Batch No. 2 (referred to as Sunscreen Soap 2
and assigned AMA Lab No.: K-7598) was subjected to an "In Use"
Test. The subjects tested were again five people, ranging in age
from 20 to 53, who were all Caucasian females. No adverse effects
or unexpected reactions of any kind were observed on any of the
subjects.
[0139] An "In-Use" evaluation procedure was followed for this test,
whereby study participants were instructed to lather the test
material on the forearm test sites and rinse in a manner consistent
with which they would typically was with a soap product. Their
formearms were then exposed to UV rays from the solar simulator.
Otherwise, same protocols were followed as in the previous
tests.
[0140] Results: The SPF of the above test material when tested on
five subjects as described herein under static, "In-Use" conditions
yielded the mean SPF of 3.92. The mean SPF of the 8% homosalate
standard on the same panel was 4.24. TABLE-US-00004 TABLE 4 (Batch
No. 1 (In Use Test): Sunscreen Soap 2) MED MED STD Subject MED/ I
Skin I II (8% SPF ID # Sex Hr (Amps) Type J/M.sup.2 J/M.sup.2 HMS)
Value 64 7285 F 125.4 7.8 II 60.89 60.89 4.40 3.20 46 9012 F 128.1
7.8 II 46.20 46.20 4.00 4.00 40 8279 F 126.2 7.8 II 46.89 46.89
4.40 4.40 50 1415 F 127.6 7.7 II 46.20 60.89 4.00 4.00 58 3434 F
126.5 7.2 II 30.33 30.33 4.40 4.00 Mean (x) 4.24 3.92 Standard 0.22
0.44 Dev (s) Std. Error 0.10 0.20 S.E. % of 2.36 5.10 Mean N 5 5
MED: Minimal Erythemal Dose I: Intensity of Light Source
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